Regulation - EUON
Manufacturing - Overview - Regulation Text
There is no specific legislation that addresses manufacturing processes for nanomaterials. There are mandatory reporting schemes, known as nanomaterial registries, which monitor activity on manufacturing of nanomaterials (including their importation and distribution).
In terms of nanotechnology regulation, the European Union is well-advanced but not alone in seeing the need for greater scrutiny on the use of nanotechnologies. To facilitate regulation, inter alia, a definition of nanomaterials has been defined by the European Commission in its Recommendation on the Definition of a Nanomaterial - 2011/696/EU. This non-binding document has also been used by other pieces of regulation to define the term ‘nanomaterial’. Some key regulatory documents within the European Union as a whole and within Member States include:
- Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - 1907/2006(EC)
- European Commission Recommendation on the Definition of a Nanomaterial
|Status||Name of the document||Country/Region||Scope||Nano-specific|
|Implemented||Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - 1907/2006(EC)||EU||Chemicals & Raw Materials||No, but 'substance' covers nanomaterials|
|Implemented||Decree on the annual declaration on substances at nanoscale - 2012-232||France||Substance at the nanoscale||Yes|
|Implemented||European Commission Recommendation on the Definition of a Nanomaterial||EU||Substances at the nanoscale||Yes|
|Implemented||Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale||Belgium||Substances manufactured at the nanoscale||Yes|
|Implemented||Order on a Register of Mixtures and Articles that contain Nanomaterials as well as the Requirement for Manufacturers and Importers to report to the Register – BEK nr 644||Denmark||Nanomaterials||Yes|
The EU is actively developing a set of regulations related to nanotechnology. With the first Regulatory Review on Nanomaterials SEC (2008) 2036 and the Second Regulatory Review on Nanomaterials SWD (2012) 288 final, the EC has given Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) a central role in regulating nanomaterials. “There are no provisions in REACH referring explicitly to nanomaterials. However, nanomaterials are covered by the ‘substance’ definition in REACH”, states the 2008 Communication.
Since the summer of 2013, there has been ongoing work to adapt the Annexes of REACH to specifically address nanomaterials; an impact assessment and a large consultation on this issue have been run by the European Commission but discussions are still ongoing.
One of the milestones of the European Regulatory Framework for nanotechnologies is the European Commission Recommendation on the Definition of a Nanomaterial. This non-binding document has been used by other pieces of regulation that needed to define the term ‘nanomaterial’.
The definition is the following:
“2. ‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.”
Developed in 2011, this definition is undergoing a review process that should have been concluded in December 2014; an outcome of this review could be a revision of the definition.
Other definitions have been developed inside the legal text of several sectorial regulations which address nanomaterials (from biocides to food).
While the European Union has been developing a regulatory framework for nanomaterials under REACH, some European Member States have sought to find additional ways to regulate nanotechnologies. In recent years, databases and reporting schemes for nanomaterials have been developed in Europe. Whilst these are not specific to the market sector covered by this report, they are still relevant to the regulation of nanotechnologies.
Under the Belgian Presidency of the European Union, in 2010, the European Union has opened the discussion on a 'harmonized database of nanomaterials’; it was followed by a 2012 letter to the European Commission calling for a European Reporting Scheme and signed 10 European Member States, plus Croatia. The European institutions are still weighing the pros and cons of such a reporting scheme; nevertheless, some European Member States have been moving forward.
In addition, as part of the electoral promises of the 2007 Presidential Elections, the ‘Grenelle de l’Environnement’, a large environmental debate was organized in France and resulted in major environmental acts: the Grenelle Acts (Lois Grenelle I & II) which enacted the future creation of a mandatory reporting scheme for nanomaterials. France hence took steps towards setting up the first registration scheme for substances at the nano-scale in Europe; in 2012, the Decree1 on the annual declaration on substances at nano-scale - 2012-232 was published; it came into force on 1 January 2013. It grants to the French Agency for Food Safety, the Environment and Labour (ANSES) the authority to collect “information from a production, distribution, import of nano-scale substances of 100 grams”.
The Belgian FPS (Public Health, Food Chain Safety and Environment) has also been working on a similar scheme: in February 2014, the Belgian Council of Ministers validated the Royal Decree regarding the Placement on the Market of Substances manufactured at the Nano-scale2. The registration of substances will begin from 1 January 2016, while mixtures will have to be registered from 1 January 2017.
In June 2014, the Danish Order on a Register of Mixtures and Articles that contain Nanomaterials as well as the Requirement for Manufacturers and Importers to report to the Register - BEK nr 644 came into force. With this Order, the Ministry of the Environment creates a national mandatory database of nanomaterial-containing products that will register the first products for the year 2014 in the year 2015.
Other EU Member States have been considering options for a registration scheme for nanomaterials; Norway considers such a register under its Pollution Control Authority (SFT). From 2013, the Norwegian Product Register requires information for chemicals containing ‘a substance in nano form’ with a ‘tickbox’ system. Sweden has given the mandate to its chemical agency (KEMI) to develop a reporting scheme and Italy is also considering setting up a similar system.
With these initiatives, EU Member States have been encouraging the European Commission to act; the Second Regulatory Review on Nanomaterials of 2012 included an impact assessment of potential transparency measures which include approaches similar to the reporting schemes set in action in several Member States. The Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market was led by a RPA and BiPro; three reports were published to help the EC decide on an eventual EU-wide registry of nanomaterials. To date, there has been no decision.
Regulation in the rest of the world
In the United States of America, the Toxic Substances Control Act (TSCA) is the main chemical regulation. The US Environmental Protection Agency (EPA) is in charge of adapting this regulation to nanoscale materials (the US authorities have decided not to write a binding definition of a nanomaterial). The latest regulatory initiative was taken by US EPA in April 2015 with the publication of a proposed rule for section 8 (a) of the Toxic Substances Control Act (TSCA). This proposal would introduce reporting and recordkeeping requirements for nanoscale materials as well as a 135-days pre-notification requirement for the manufacturers of ‘chemical substances as discrete nanoscale materials’.
In Canada, Health Canada and Environment Canada have been looking at similar approaches; in April 2015 they opened a consultation on a Proposed Approach to address Nanoscale Forms of Substances in the Domestic Substances List. The DSL lists substances that are manufactured in or imported into Canada Established under the Canadian Environmental Protection Act (CEPA 1999). With this “proposed approach” the Canadians intend to establish a list of existing nanomaterials in Canada with the use of ‘a mandatory survey under section 71 of the Act […] to obtain the essential data needs to support the development of the list of the existing nanomaterials in Canada and subsequent prioritisation activities for those substances’.
- Décret n° 2012-232 du 17 février 2012 relatif à la déclaration annuelle des substances à l'état nanoparticulaire pris en application de l'article L. 523-4 du code de l'environnement
- Koninklijk besluit betreffende het op de markt brengen van als nanodeeltjes geproduceerde stiffen or Arrêté royal relatif à la mise sur le marché des substances manufacturées à l’état nanoparticulaire